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FDA 510(k)

PF404/409/410/411/416/418 W/PF319:0/319:1/319:2

K-Number: K935495 · 1994-04-18

ApplicantPerimed, Inc.
Decision Date1994-04-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 is the device name listed in this FDA 510(k) record. The listed applicant is Perimed, Inc.. It received FDA 510(k) clearance on 1994-04-18 under 510(k) number K935495. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PF404/409/410/411/416/418 W/PF319:0/319:1/319:2?

PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 is a medical device that received FDA 510(k) clearance on 1994-04-18. The listed applicant is Perimed, Inc.. The 510(k) number is K935495.

When did PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 receive FDA 510(k) clearance?

PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 received FDA 510(k) clearance on 1994-04-18, under 510(k) number K935495.

Who is the listed applicant for PF404/409/410/411/416/418 W/PF319:0/319:1/319:2?

The FDA 510(k) record lists Perimed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF404/409/410/411/416/418 W/PF319:0/319:1/319:2?

The FDA product code for PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 is GEX. This falls under the Gastroenterology category.

Other records listing Perimed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K990960PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)K974285PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNITK932068PERITEMP PF 4005 HEATERK922368PERIFLUX PF4001 LASER DOPPLER FLOWMETERK890828PERIFLUX PF3

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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